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Bill to increase oversight of cosmetic surgery centers making late push in Assembly

Legislation clears House with a week remaining for Senate action

By Scott Dance, The Baltimore Sun

6:40 p.m. EDT, April 1, 2013

A bill to give health regulators more oversight of facilities like the now-closed Monarch Medspa in Timonium is making a late surge in the General Assembly after weeks of discussions among state and industry officials.

The House of Delegates unanimously passed the legislation Monday afternoon. It needs to clear the Senate, including an extra procedural step, within the next week. The legislative session draws to a close April 8.

If passed, the law would close a regulatory gap that does not allow state health officials to proactively inspect and oversee plastic surgery centers. While doctors working in the facilities are licensed, the centers themselves are not. But health officials argue they should be, given the risk involved in many cosmetic surgery procedures.

That risk was demonstrated, they said, when a Lochearn woman died after a liposuction procedure at the Timonium medical spa. She and two other patients who were treated at the spa contracted severe infections, prompting state health officials to close the facility in September.

Regulators and industry stakeholders began talks over possible increased oversight of medical spas just after the closure was announced. The state health department and Del. Kirill Reznik, a Montgomery County Democrat, each introduced bills addressing the concern early in the legislative session, which began in January. But the legislation was held up by disagreements over the approach.

There were concerns from dermatologists, for example, that expanding the definition of cosmetic surgery procedures in state law and regulations would mean they could end up needing to license their office as a cosmetic surgery center. Under state law that pertains to the Board of Physicians, doctors can remove 1,000 cubic centimeters of fat or less from patients in their offices, but must go to a surgery center for any larger amount, for example.

As a compromise, legislation passed by the House would not change that legal definition. Instead, it would give state health officials the authority to adjust regulations of plastic surgery procedures if they found that any in particular pose substantial health and safety risks.

"We think this is a step in the right direction," said Gene Ransom, executive director of MedChi, the state medical society. "This clearly addresses the issue where people are doing things that should be done in a hospital or ambulatory care center."

The approach leaves any future regulation of the facilities up in the air, but one lawmaker who helped guide the compromise said that helped satisfy industry groups. A similar approach was taken with oversight of abortion clinics in 2012, and led health officials last month to close three clinics, including one in Baltimore where a patient died.

"We have a lot of confidence that [state health officials] will look at what needs to be done, and not do more than what needs to be done to keep the citizens of Maryland safe," said Del. Shane Pendergrass, a Howard County Democrat.

Many plastic surgery centers in Maryland are not required to be licensed as ambulatory surgical centers because they bill patients directly, rather than billing insurance companies or government insurance programs. Part of the legal definition of regulated surgical centers involves how patients are billed.

Some in the industry said it can be difficult for consumers to tell whether a plastic surgery center is safe, with no guarantees even if "medical" appears in its name. Even procedures as routine as mole removal carry some risk, one plastic surgeon said.

"Anytime you're doing a plastic surgery procedure that's invasive, like liposuction, it should be done in an accredited surgery center," said Dr. Michael D. Cohen, medical director of the Cosmetic Surgery Center of Maryland. "Anytime you remove skin, that's invasive."

A state law passed in 2010 added some state oversight of plastic surgeons, but it did not address the surgery centers themselves. Under the law, the state Board of Physicians can discipline doctors who perform certain cosmetic procedures in unlicensed or unaccredited facilities. The law does not apply to liposuction procedures in which less than 1,000 cubic centimeters of fat are removed, or any procedures in which only local anesthesia is administered.

In the Monarch case, the three patients who underwent liposuction at the Timonium facility contracted infections of a bacteria known as group A staphylococcus, the state health department said. The bacteria is the same one that causes strep throat and other common illnesses but is rarer and more dangerous when infecting the skin and other body parts. The state said its inspectors observed "probable deviations from standard infection control practices" at the center.

Monarch officials could not be reached for comment Monday. In a statement when the infections came to light, they extended sympathies, called the incidents "a new development" and pledged to work with authorities on the investigation.

Monarch was not among a list of certified ambulatory surgical centers in the state, according to the Maryland Health Care Commission, and does not list any accreditations on its website.

The Timonium center is no longer listed among Monarch's locations on its website. Other Monarch locations are in the Philadelphia area and Harrisburg, Pa.